Throughout the 2015 AAMI conference in Denver June 6–8, staffers scrambled to expand room capacity on the fly as session audiences ballooned beyond the expected capacity—a byproduct of AAMI’s largest gathering to date. Correctly anticipating that George Mills’ update on Joint Commission (TJC) activities and the subsequent Q&A session would strain resources even further, the association preemptively relocated the sessions to the main ballroom, communicated in a last-minute Sunday night email. That was a relief for attendees who have been previously squeezed out of his standing-room-only sessions. Mills spoke about some of the most common issues The Joint Commission has observed in its visits to hospitals. Temperature, humidity, and ventilation concerns are a frequent problem as they overlap with facilities, and can contribute to mold growth and hospital-acquired infections. Each year approximately 700,000 patients in the United States come down with such an infection, Mills noted, and about 80,000 die. Endoscope reprocessing, also appearing on ECRI Institute’s list of Top 10 Patient Safety Concerns, should be a matter of concern for biomeds, Mills stressed. He urged attendees to visit central sterilization periodically to review sterilization procedures and look for potential sources of cross-contamination, such as used endoscopes being processed too closely to sterilized devices. Mills also returned to the Centers for Medicare and Medicaid Services’ (CMS) December 2013 memo on preventive maintenance and alternative equipment maintenance (AEM) programs, a document that continues to generate questions and confusion from HTM departments. The topic was clearly a source of interest for many attendees. According to CMS, Mills said, ambulatory surgery centers are not eligible for an AEM program, although critical access hospitals may implement one. He also clarified the distinction between TJC guidelines’ use of the term “high risk” versus CMS’ term “critical” equipment. “‘High risk’ is just me saying I’m not going to use the word ‘critical,’ ” Mills said. “Sorry for the confusion, but ‘high risk’ is exactly equivalent to CMS’ definition of ‘critical.” He further clarified that “high risk” has a broader definition than merely life support equipment. For example, defibrillators are not technically life support devices, since they are used to resuscitate patients, but they still stand to enable loss of life if they fail. Likewise, a surgical robot could also cause serious harm if it didn’t function properly. However, Mills warned, “Just because [a device is] high risk doesn’t automatically mean it’s high PM.” The AEM program option negotiated with CMS was designed to give biomeds “freedom to make rational decisions,” he said. “You have to use some common sense.” During the question and answer portion of his talk, Mills fielded several requests for clarification on specific aspects of the AEM program guidelines and advice for particular situations. For imaging equipment ineligible for an AEM program, deviating from OEM guidelines in almost any respect can be problematic. Doing PM procedures more frequently than required, or adding on a procedure that is not explicitly noted in the OEM guidelines, such as regularly defragmenting the PC associated with an ultrasound unit, must generally be either cleared by the OEM or considered alternative maintenance. Mills apologized, explaining, “We’re in this box.” In one case, an attendee asked about a device that uses ultrasound technology but that doesn’t deliver any therapy to patients. According to strict interpretation of CMS guidelines, such units must still be PMed according to OEM guidelines, Mills said. Mills also advised attendees to check out the ANSI/AAMI standard EQ89 as a high-level resource for building an HTM department and bringing up staffing levels. It’s “not a cookbook,” Mills said, but the document could provide helpful resources for HTM professionals.
My understanding of outpatient surgery centers is this: If an outpatient surgery center is covered by the hospital’s accreditation program, it can have an AEM program. Completely standalone outpatient surgery centers who are accredited directly and independently from a hospital cannot have an AEM program. This was discussed by Mr. Mills at an ASHE conference in October, 2014.
I haven’t kept up on the AEM issue; I play no role in addressing it in my organization. But I am intrigued by it, as I’ve played plenty of equipment management roles over the past 36+ years. So if the following has been definitively answered for everyone who is impacted by the recent changes, forgive me for asking:
Exactly what problems do these changes address?
The leads to other questions:
Where is the data that demonstrates the existence and real consequences of the problems?
How has the opportunity cost issue been addressed, i.e., what is not being done because resources have been diverted to addressing these changes?
What are the consequences of not doing the things that have had their resources diverted, and how have those consequences been weighed against those associated with the recent changes?
Pointers to where that has been documented would be enough to satisfy my curiosity. Thanks.
There is a follow-up to the unanswered questions of “Exactly what problems do these changes address?” and “Where is the data that demonstrates the existence and real consequences of the problems?
This question is: What data will be collected to show that the problem has been eliminated or reduced ?
The assumption that medical equipment manufacturers know best about what a hospital needs to do to maintain its equipment is seriously flawed. You should only assume that manufacturers know what is in their best interest. Manufacturers should supply recommendations and these recommendations should be seriously considered in making equipment support and replacement decisions. But CMS and the Joint Commission should not try to make them edicts. What was the need to demand such sweeping changes? I am sure that manufacturers can cite many specific situations, but that is what they are: specific concerns that can be addressed specifically, not with sweeping edicts in general.
I strongly agree with your comment. Manufacturers are only obligated to cover themselves. They have many regulations to clear and considerations to process when bringing new device or updated device to market. They can’t possibly predict nor simulate the variances in the frequency of use on their devices. One facility might use a device 2 to 3 times a day and another might use it 10 to 15 times a day.
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